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Think Surgical, Inc. announced that its TMINI miniature robotic system has received 510(k) clearance from the US Food and Drug Administration.
The system, developed with Sagentia Innovations, includes a wireless robotic handpiece to help surgeons perform total knee replacements, replacing many of the instruments currently used for knee replacement surgery.
It uses CT-based, three-dimensional surgical planning to automatically compensate for surgeon hand movement to locate bone pins along precisely defined planes. The cutting guides are then attached to the bone pins for precise bone resection.
Stuart Simpson, Think Surgical CEO, said: “We are delighted that the TMINI system has received 510(k) clearance from the FDA. We are now in a position to bring this exciting product to market.
“The TMINI system truly transforms Think Surgical’s position in the marketplace. This allows us to focus on driving the adoption of robotic technology across the majority segment of the market. By offering an easy-to-use, miniature robot, we can open up a new segment of the market, while improving access for more patients.
Think Surgical has adopted an open implant library approach and will continue to add new implant options to the platform in the future.
The company selected Sagentia Innovation to support key aspects of the development of the TMINI system. Tim Freerson, Project Manager for Sagentia Innovations TMINI, said: “We supported Think Surgical in very specific aspects of the technical development of the TMINI system to achieve the targeted outcomes. Many of these related to important factors such as ease of use, Meeting sterilization needs and enhancing battery and power management.
With FDA approval the TMINI system has the potential to advance robotic-assisted surgery (RAS), thanks to its small footprint, open implant platform and intuitive workflow.
Thanks to the many advantages RAS can provide, we are increasingly seeing surgeons assisted by robots with laser precision. Last year, NHS Highland revealed it was able to halve the length of hospital stay for some patients, while also reducing the risk of post-surgery complications after introducing a surgical robot.
